Quality Control Lead - Medical Devices

Nordson; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

Nordson Medical - Surgical Solutions, Quality in Allen, TX is seeking a hands-on Quality Control Supervisor to lead daily quality inspection and testing activities in a regulated medical device manufacturing environment.

You will supervise Quality Control Technicians, support production priorities, and ensure inspection, documentation, calibration, and environmental monitoring comply with company procedures, FDA requirements, and ISO 13485.

Qualifications

• 5+ years of quality experience in medical device manufacturing, including cleanroom operations.
• 3+ years of supervisory experience.
• Knowledge of FDA Quality System requirements, ISO 13485, GMP.
• Strong leadership and communication skills in a fast-paced environment.

Responsibilities

• Lead, train, schedule, and develop Quality Control and Calibration Technicians.
• Oversee incoming, in-process, and finished-goods inspection and testing.
• Ensure inspection records and quality documentation are accurate and compliant.
• Partner with Quality, Operations, and Engineering to investigate nonconformances.
• Manage the calibration program and support measurement-system improvements.
• Monitor environmental monitoring and particle-count activities, including data review and trend reporting.
• Coordinate cycle counts, inventory reconciliation, quality holds, and related ERP transactions.
• Support new-product introduction, process improvements, yield improvement, and manufacturability initiatives.
• Reinforce safety, attendance, and company policy expectations.
• Provide hands-on inspection support when needed to meet business priorities.

Skills

Leadership

Quality inspection

Documentation

Problem-solving

Communication

Regulatory knowledge

Education

High school diploma

Associates or Bachelor's in science/engineering

Job description

Nordson Medical - Surgical Solutions, Quality in Allen, TX is seeking a hands-on Quality Control Supervisor to lead daily quality inspection and testing activities in a regulated medical device manufacturing environment.

You will supervise Quality Control Technicians, support production priorities, and ensure inspection, documentation, calibration, and environmental monitoring comply with company procedures, FDA requirements, and ISO 13485.